Drugs

FDA Promo Violation Letter on Qsymia Web Page

CDER’s Office of Prescription Drug Promotion (OPDP) has issued Vivus an untitled letter over false and misleading claims made on its Web page for weight-loss drug Qsymia (phentermine and topiramate extended-release) capsules. According to the letter, the page makes false/misleading claims and representations about the drug’s efficacy and risks. “The Web page is especially concerning from a public health perspective because it creates a misleading impression regarding the overall effect a patient may expect as a result of Qsymia treatment and deemphasizes the risks associated with taking the drug," OPDP writes Vivus. “Consumers and patients who seek assistance with their weight-loss goals should not be misled regarding the actual benefits, serious risks, and necessary nutritional and lifestyle modifications associated with the use of a weight management prescription drug product, such as Qsymia.”

OPDP says it has issues with claims suggesting three-times faster weight loss from using the drug. It says that cited references do not support this suggestion and it is not aware of data to support such claims. Additionally, OPDP says the Web page fails to present information relating to contraindications, warnings, precautions, and adverse reactions for Qsymia with a “prominence and readability reasonably comparable with the presentation of information relating to the benefits... Factors impacting prominence and readability include typography, layout, contrast, headlines, paragraphing, white space, and other techniques apt to achieve emphasis. Specifically, benefit claims for Qsymia are presented in conjunction with colorful graphics and large bolded headlines, with significant white space. However, the risk information is relegated to the bottom of the Web page in paragraph format and is not easily accessible to viewers who must scroll down the Web page past the entire benefit presentation.” And, it says the page does not present any significant signal to alert the viewer that important risk information follows the benefit information.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome